Clearance Summary
Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe received FDA 510(k) clearance under submission number K213013, sponsored by Jeil Tech Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2022-09-19.
- Submission: K213013
- Applicant / Sponsor: Jeil Tech Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2022-09-19
Classification & Regulation
This clearance is catalogued under FDA product code QNQ and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.